Follicular LymphomaPhase 2NCT06549335
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
A Phase 2 study testing Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in people with Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Indications for treatment confirmed
- Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
- Must has measurable lesion in CT or PET-CT prior to treatment
- Considered suitable for ZGR regimens
- Informed consented
Who cannot join
- Transformed follicular lymphoma or 3B follicular lymphoma;
- HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
- Any drug contraindication in the treatment plan
- Pregnant or lactating women
- Patients judged by other researchers to be unsuitable for inclusion in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma
This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas
- Conditions
- Follicular Lymphoma
- Being tested
- Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
- Keywords
- Zanubrutinib, Lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)Drug
Induction therapy:
The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles.
Dosage:
- Zanubrutinib, 160 mg bid, po, day 1-28;
- Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6);
- Lenalidomide, 25 mg qd, po, day 2-11.
Maintenance therapy:
- Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years;
- Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) | Experimental | Not described Receives: Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (5)
Complete response rate (CR)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: At the end of Cycle 6 (each cycle is 28 days)
Partial response rate (PR)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: At the end of Cycle 6 (each cycle is 28 days)
Duration of response
Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Measured: Baseline up to data cut-off (up to approximately 2 years)
2-year progression free survival rate
progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
2-year overall survival rate
progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549335
- Sponsor's protocol ID
- FL-ZGR
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT06549335
- Acronym / sponsor ID
- FL-ZGR
- Conditions
- Follicular Lymphoma
- Keywords
- Zanubrutinib, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) | Experimental | Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Indications for treatment confirmed
- Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
Key exclusion criteria (5 listed)
- Transformed follicular lymphoma or 3B follicular lymphoma;
- HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
- Any drug contraindication in the treatment plan
- Pregnant or lactating women
- Patients judged by other researchers to be unsuitable for inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)Induction therapy: The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles. Dosage: 1. Zanubrutinib, 160 mg bid, po, day 1-28; 2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6); 3. Lenalidomide, 25 mg qd, po, day 2-11. Maintenance therapy: 1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years; 2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles. | Drug | Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) |
Primary outcome
Objective response rate (ORR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
5 secondary outcomes
Complete response rate (CR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Partial response rate (PR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Duration of response
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2-year progression free survival rate
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2-year overall survival rate
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in people with Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, M.D. and Ph.D (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: At the end of Cycle 6 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.